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| Sponsor: | National Center for Research Resources (NCRR) |
|---|---|
| Collaborator: |
University of Alabama at Birmingham |
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00006135 |
Purpose
OBJECTIVES:
I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection limited to skin, eyes, and mouth.
II. Determine the neurologic outcome in these patients when treated with this regimen.
III. Evaluate the significance of a positive cerebrospinal fluid (CSF) polymerase chain reaction (PCR) result when all other CSF parameters remain normal in these patients.
IV. Correlate the time to first positive CSF PCR result in the first 12 months of life with clinical neurological assessment in these patients when treated with this regimen.
V. Determine whether the continuous administration of this drug suppresses recurrent skin lesions in these patients.
VI. Determine the safety of this regimen in these patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Simplex |
Drug: acyclovir |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Estimated Enrollment: | 66 |
| Study Start Date: | June 1997 |
PROTOCOL OUTLINE:
This is a randomized, double blind, placebo controlled, multicenter study.
All patients undergo a lumbar puncture and then receive acyclovir IV every 8 hours on Days 1-14. On Day 12, patients may undergo a lumbar puncture (at discretion of investigator). Whole blood is obtained for herpes simplex virus PCR analysis. Upon completion of intravenous therapy, patients with a negative CSF PCR are randomized to one of two treatment arms.
Arm I: Patients receive oral acyclovir three times daily for 6 months.
Arm II: Patients receive placebo three times daily for 6 months.
In case of cutaneous recurrence during the first 12 months of the study, patients receive open label oral acyclovir (if CSF PCR is negative) or acyclovir IV (if CSF PCR is positive) for 5 days. Patients may or may not continue on study drug following this treatment.
Patients are followed at 6, 12, 24, 36, 48, and 60 months of age.
Eligibility| Ages Eligible for Study: | up to 28 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Infants diagnosed with herpes simplex virus infection limited to skin, eyes, and mouth; HSV-1 or HSV-2 isolated from cutaneous lesions, conjunctivae, or oropharynx (presence of skin lesions not required); normal CSF indices: WBC less than 22/mm3 and protein less than 115 mg/dL for term infants OR WBC less than 25/mm3 and protein less than 220 mg/dL for preterm infants; no evidence of CNS involvement by CT with contrast, MRI with gadolinium, or head ultrasound; no visceral dissemination (normal liver function tests, normal chest x-ray, etc.); negative CSF PCR result
Birth weight at least 800 grams
--Prior/Concurrent Therapy--
No concurrent nursing from a mother who is receiving acyclovir, valacyclovir, or famciclovir for longer than 120 hours or 5 days; no prior prophylactic acyclovir for risk of herpes simplex virus infection
--Patient Characteristics--
Renal: Creatinine no greater than 1.5 mg/dL
Cardiovascular: No prior grade 3 or 4 intraventricular hemorrhage
Other: No infants known to be born to HIV-positive women
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Children's Hospital of Alabama | |
| Birmingham, Alabama, United States, 35233 | |
| University of Alabama Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arkansas | |
| University of Arkansas | |
| Little Rock, Arkansas, United States, 72202 | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Children's Hospital and Health Center | |
| San Diego, California, United States, 92123-4282 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Florida | |
| University of Florida Health Science Center - Jacksonville | |
| Jacksonville, Florida, United States, 32209 | |
| United States, Louisiana | |
| Tulane University Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| St. Louis Children's Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New York | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| United States, Ohio | |
| Children's Hospital Medical Center - Cincinnati | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| Ohio State University Children's Hospital | |
| Columbus, Ohio, United States, 43205-2696 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, Tennessee | |
| University of Tennessee Medical Center at Knoxville | |
| Knoxville, Tennessee, United States, 37920 | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232-6305 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| University of Texas Southwestern Medical School | |
| Dallas, Texas, United States, 75235-9032 | |
| Canada, Alberta | |
| University of Alberta | |
| Edmonton, Alberta, Canada, T6G 2R7 | |
| Canada, Manitoba | |
| University of Manitoba-Winnipeg | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Study Chair: | David W. Kimberlin | University of Alabama at Birmingham |
More Information
| Study ID Numbers: | 199/15334, UAB-CASG-104 |
| Study First Received: | August 3, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006135 History of Changes |
| Health Authority: | United States: Federal Government |
|
herpes simplex virus infection herpesvirus infection immunologic disorders and infectious disorders rare disease viral infection |
|
Skin Diseases, Viral Virus Diseases Herpes Simplex Anti-Infective Agents Skin Diseases, Infectious Acyclovir |
Skin Diseases Therapeutic Uses DNA Virus Infections Antiviral Agents Pharmacologic Actions Herpesviridae Infections |
